FDA.reportPublic FDA data

Colour Liquid C3 (20 ml)

Primary DI
D800FMAA12030
Brand
Colour Liquid C3 (20 ml)
Company
ZIRKONZAHN SRL
Model
FMAA1203
Device description
Content: 20 ml
Published
2026-05-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIHPOWDER, PORCELAIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D800FMAA12030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental articulation paste/solutionA substance intended to characterize the contact relationship between the maxillary and the mandibular teeth during occlusion, and between interproximal surfaces, to help determine the proper seating of full or partial dentures, crowns and bridges, and to program and/or assess progress of orthodontic treatment. It may include one or more substances (e.g., wetting spray, silicone paste, drying liquid that turns into a removable film) and is designed to be applied to the teeth or a restorative prosthesis to show the contact surfaces in situ or on a substrate (e.g., impression material) that displays visible marks when the patient bites. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
+390474066660info@zirkonzahn.com

Regulatory Flags#

DUNS number
564251911
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D800FMAA01030Colour Liquid A1 (20 ml)FMAA01032026-05-28
D800FMAA04030Colour Liquid A3,5 (20 ml)FMAA04032026-05-28
D800FMAA05030Colour Liquid A4 (20 ml)FMAA05032026-05-28
D800FMAA06030Colour Liquid B1 (20 ml)FMAA06032026-05-28
D800FMAA07030Colour Liquid B2 (20 ml)FMAA07032026-05-28
D800FMAA08030Colour Liquid B3 (20 ml)FMAA08032026-05-28
D800FMAA09030Colour Liquid B4 (20 ml)FMAA09032026-05-28
D800FMAA10030Colour Liquid C1 (20 ml)FMAA10032026-05-28
D800FMAA11030Colour Liquid C2 (20 ml)FMAA11032026-05-28
D800FMAA13030Colour Liquid C4 (20 ml)FMAA13032026-05-28
D800FMAA14030Colour Liquid D2 (20 ml)FMAA14032026-05-28
D800FMAA15030Colour Liquid D3 (20 ml)FMAA15032026-05-28
D800FMAA16030Colour Liquid D4 (20 ml)FMAA16032026-05-28
D800FMAA17030Set Colour Liquid (20 ml)FMAA17032026-05-28
D800FMAA19030Colour Liquid Thinner (20 ml)FMAA19032026-05-28
D800FMAA20030Colour Liquid Stabilizer (20 ml)FMAA20032026-05-28
D800FMAA31020Colour Liquid Prettau A1 (100 ml)FMAA31022026-05-28
D800FMAA31030Colour Liquid Prettau A1 (20 ml)FMAA31032026-05-28
D800FMAA32020Colour Liquid Prettau A2 (100 ml)FMAA32022026-05-28
D800FMAA32030Colour Liquid Prettau A2 (20 ml)FMAA32032026-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06976581410009Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410016Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410023Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410030Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410047Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410054Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410061Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410078Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
EDDI963011DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963051DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963061DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963071DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963081DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963091DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963161DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963171DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963431DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963441DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963451DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963821DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963831DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963841DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963851DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963861DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963941DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963951DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963961DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963971DD cubeY® HLDental Direkt GmbHEIH2026-06-02
D800FMAA01030Colour Liquid A1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA04030Colour Liquid A3,5 (20 ml)ZIRKONZAHN SRLEIH2026-05-28